Medication dispenser with integrated monitoring system

ABSTRACT

Devices, systems, and methods are provided for remote visualization of the storage compartments in a medication dispenser device, to monitor a patient&#39;s compliance with a medication dosage schedule and for verifying the proper loading of medication into the patient&#39;s medication dispenser device. The device may include a plurality of storage compartments, each having an interior space for storing at least one medication or medication reminder marker; an image capturing device (e.g., a camera) positionable to capture an image of the interior space of each storage compartment; and a communications module for electronically transmitting the captured image to a central monitoring station.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. application Ser. No. 13/269,981, filedOct. 10, 2011, which is a continuation of U.S. application Ser. No.11/943,451, filed Nov. 20, 2007, which claims priority to and thebenefit of U.S. Provisional Application No. 60/866,916, filed Nov. 22,2006. The applications are incorporated herein by reference in theirentirety.

BACKGROUND

Patient compliance with medication dosing schedules is a seriousproblem. Approximately 60% of prescribed medication is not taken asdirected. Non-compliance leads to worsening illness, hospitalization,irreversible loss of function, and death, resulting in tremendous humanand financial costs. When medicines are dispensed, especially outsidehospitals, errors in selection of the correct pill and the appropriatedose add further morbidity and mortality.

For example, elderly patients and patients taking multiple medicationsat different dosing schedules may have difficulty remembering to taketheir medications at the scheduled times. Approximately 90% of elderlypatients make medication errors, 35% of which are serious. Approximately40% of all hospital admissions among elderly patients are due tomedication problems.

Other medications, such as opioid analgesics and narcotics, may be proneto abuse or diversion, for instance taken in excess or diverted and soldto others who would abuse the medication. Groups of people in whichnon-compliance is a common problem include Americans with chronicdisease, diabetes (approximately 18 million), cardiovascular diseases(approximately 58 million), depression (approximately 20 million), andasthma (approximately 17 million).

It would be desirable to enhance patient adherence to dosing schedulesfor prescription medications. It would be useful to provide a low-costdispenser and monitoring system to verify that medications storedtherein are not taken in excess (i.e., abused) and that vitalmedications doses are not skipped. It also would be useful to provide adispenser and monitoring system to verify that medications storedtherein are removed by the patient, or an authorized person, in order toprevent diversion.

SUMMARY

The present devices for the monitored storage and dispensing ofmedication comprise a plurality of storage compartments, wherein eachstorage compartment has an interior space for storing at least onemedication or at least one medication reminder marker; an imagecapturing device positionable to capture an image of the interior spaceof each of the plurality of storage compartments; and a communicationsmodule for electronically transmitting the image captured by the imagecapturing device to a central monitoring station. In one embodiment,each storage compartment comprises a wall through which the image can becaptured. In one embodiment, one or more of the storage compartmentscomprise a plurality of solid oral dosage forms of one or moremedications. In another embodiment, the storage compartments comprise atleast one medication reminder marker that comprises an object with ashape and color selected to match a shape and color code present on alabel of a prescribed medication, such as an inhaler or a parenteralmedication.

In certain embodiments, the plurality of storage compartments isprovided in an array corresponding to the days of the week and periodsof time throughout the day. In certain embodiments, the storagecompartments are replaceably removable from the device, either in oneunit or in two or more subunits of two or more storage compartments. Inone embodiment, each subunit comprises compartments corresponding to atleast one day of the week. In a preferred embodiment, the imagecapturing device comprises a camera. The camera may be a digital stillcamera or a digital video camera. A modified flat bed scanner, based ona linear array of CCD devices, could also be used for digital imagecapture. In certain embodiments, the communications module forelectronically transmitting at least a portion of the captured imagecomprises a network link for a telephone line, power line, wirelessgateway, or cellular network. The network link may, for example,comprise an embedded or dongle circuitry for WiFi, zigbee, powerline, orbluetooth transmission circuitry.

In one embodiment, the device includes an electronic communicationscomponent for communicating information to a user of the dispenser, froma user of the dispenser to the central monitoring station, or both toand from the user. The communications component may include at least oneaudio, visual, or tactile means for communicating information. Forexample, the information communicated to the user may include batterypower level or other operational status information about the device, orinformation about the user's compliance with his or her medicationdosage schedule. Information communicated from the user may includepersonal identity information of the user of the dispenser, e.g., formedication security purposes. In various other embodiments, theinformation comprises contact information for the patient's doctor,pharmacy, caregiver, or other emergency contact; music preferenceinformation; or weather, news, or sports information.

In another aspect, the present patient medication compliance monitoringsystems comprise at least one visually monitored medication dispenserassigned to an individual patient having a medication dosage schedule,wherein the medication dispenser comprises a plurality of storagecompartments, wherein each compartment has an interior space for storingat least one medication or at least one medication reminder marker, animage capturing device positionable to capture an image of the interiorspace of each of the plurality of compartments; and a communicationsmodule for electronically transmitting the image captured by the imagecapturing device to a central monitoring station; and a centralmonitoring station capable of receiving and viewing the image from theat least one medication dispenser. In one embodiment, the systemcomprises a plurality of visually monitored medication dispensers,wherein each medication dispenser is assigned to a different individualpatient having a medication dosage schedule. In certain embodiments, theimage capturing device comprises a camera. In certain other embodiments,the communications module for electronically transmitting the capturedimage comprises a network link for a telephone line, wireless gateway,or cellular network. The medication dispenser may further comprise atleast one audio, visual, or tactile means for communicating informationfrom the user of the dispenser to the central monitoring station. Incertain other embodiments, the medication dispenser further compriseselectronic means for receiving image capture instructions from thecentral monitoring station. The system may comprise the use of at leastone computer.

In still another aspect, the present methods of monitoring a patient'scompliance with the patient's medication dosage schedule comprise thesteps of: receiving at a central monitoring station an image of aninterior space of at least one medication storage compartment within amedication dispenser device which is associated with the patient andremote from the monitoring station; and determining from the image atthe central monitoring station the presence or absence of at least onemedication or medication reminder marker in said at least one medicationstorage compartment. In certain embodiments, the methods furthercomprise the step of: transmitting to the medication dispenserinformation regarding the patient's compliance with the medicationdosage schedule. In certain other embodiments, the methods furthercomprise the step of: transmitting from the central monitoring stationan instruction to the medication dispenser to capture an image at one ormore selected times or to adjust the frequency of random capture of animage. In preferred embodiments, the received image is examined todetermine whether the presence or absence of at least one medication ormedication reminder marker matches that which is expected for thecompartment according to the medication dosage schedule. In otherpreferred embodiments, the information transmitted to the medicationdispenser device is visually displayed thereon and/or audibly broadcasttherefrom. The information transmitted to the medication dispenser, insome embodiments, may be visually displayed or audibly broadcast from anauxiliary device. The auxiliary device may be selected from a homecomputer, land-line telephone, mobile telephone, or personal digitalassistant device. In certain other embodiments, the methods furthercomprise the step of: transmitting information to a caregiver for thepatient if the image captured does not match what is expected for thecompartment of the medication dispenser device.

In yet another aspect, the present central station for medicationcompliance monitoring, comprises a memory for storingcomputer-executable instructions; and a processor in communication withthe memory, wherein the memory is operable to execute thecomputer-executable instructions to: receive at least one image from avisually monitored medication dispenser; determine, based upon thereceived image, the presence or absence of at least one medication ormedication marker according to a medication dosage schedule; andtransmit compliance information to the medication dispenser based on thedetermination.

In still a further aspect, a method is provided for verifying properloading of medication in a medication dispenser comprising the steps of:loading at least one medication or medication reminder marker into allor a subset of a plurality of medication storage compartments located inone or more containers for use in a medication dispenser device,according to a medication dosage schedule for a patient; instructing themedication dispenser to capture an image of the interior space of atleast one of the medication storage compartments and to electronicallytransmit the image to a central monitoring station; and receivinginformation from the central monitoring station verifying whether theimage corresponds to that which is expected for the medication storagecompartment according to the medication dosage schedule. The containermay be loaded with a plurality of solid oral dosage forms, medicationreminder markers, or a combination thereof. The steps may be performedby the patient, or by an automated dispenser, a pharmacist, a caregiverfor the patient, or remote operator guidance.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1A-D show a schematic diagram of one embodiment of the dispenser.FIG. 1A shows a top perspective view of one embodiment of the device ina closed position. FIG. 1B shows a perspective view of the sameembodiment of the dispenser device in an open position, showing athree-by-seven array of storage compartments. Each storage compartmenttypically is capable of accommodating a plurality of medications ormedication marker reminders. FIG. 1B shows a weekly dispenser withremovable storage compartments for accommodating up to three dosageperiods per day. Other variations of this dispenser design areenvisioned, including monthly dispensers, bimonthly dispensers, and anyof the foregoing with one, two, three, or four dosage periods per day.In one embodiment, the drug may be an opioid or other drug which may beprone to abuse, and dispenser may be for a greater number of days (e.g.,a 30 day supply) than would typically be prescribed due to the risk ofdiversion or abuse with an unmonitored prescription supply. In theembodiment shown in FIG. 1B, the storage compartments are removable as asingle unit or as two or more subunits that correspond to one or moredays of the week. FIG. 1C shows a bottom perspective view of the sameembodiment of the dispenser device. FIG. 1D shows a side view of thesame embodiment of the dispenser device.

FIG. 2 shows a cross-sectional side view of one possible embodiment thedevice, not to scale, showing storage compartments for accommodating upto three storage dosage periods per day.

FIGS. 3A and B show a schematic diagram of one embodiment of thedispenser. FIG. 3A is a partial exploded, perspective view, with asingle opened storage compartment, and FIG. 3B is a cross-sectionalview, in part, of the same embodiment of the dispenser device, showing astorage compartment with the lid opened or closed. In this embodiment,the camera is mounted to move on an X-Y platform to focus on atransparent bottom of each storage compartment. In one embodiment, eachstorage compartment may be selectively lighted (e.g., by an LED) toprovide illumination for digital visual image capture and/or forhighlighting the medication dose the patient needs to take at aparticular time. It is envisioned that a camera alternatively may bemounted on a non-movable platform.

FIG. 4 shows a process flow diagram, illustrating how one embodiment ofthe compliance monitoring system would work.

DETAILED DESCRIPTION

The present devices, methods, and systems, hereinafter referred to asthe “PillStation System” address many of the major shortfalls inoutpatient healthcare by providing a flexible central control andmonitor system utilizing adaptable bandwidth image and videosurveillance of a medication dispenser. As will be made apparent, somebenefits of the present invention include higher compliance, ease ofuse, two-way communication between patient and compliance monitor (e.g.,shaping patient behavior with positive reinforcement from the compliancemonitor), minimizing working memory demands, additional revenue (e.g.,address larger market with lower cost solutions; self-reporting servicesto physicians, family, others; data mining of medication/demographics),cost savings (e.g., fewer nurse visits and telephone calls), automatedreporting (e.g., fast reporting, more reliable reporting aboutcompliance, closed loop between the PillStation System and the patient),and better correlation of multiple regimen with illness. In addition,because the dispenser is based on conventional pill containers that aresimple and familiar to patients and caregivers, the dispenser also hasthe advantage of allowing the patient or caregiver to revert to themanual use of the storage compartments upon a power failure.

The PillStation System advantageously provides direct visualization ofthe pills a patient is to take over a period of time. The device usesthe output of a camera, CCD array, (or similar sensor and imagecapturing device) focused on the interior space of a storage compartmentin a dispenser device, wherein the output is conveyed by ordinarytelephone line, DSL, cable system, internet, cellular telephone, orother wireless network, or the like, to a central monitoring/callingsystem, where video screens and computer assisted observations byobservers facilitate a patient's compliance with his or her prescribedmedication dosage regimen. The system can provide verification thatappropriate medications have been loaded in the dispenser, removed fromthe dispenser, and/or remain loaded in the dispenser. It also canprovide surveillance from a remote location for abuse, compliance and/ordiversion. Advantageously, by having a centralized system to collect andanalyze the images (i.e., the compliance data), one may more costeffectively conduct the compliance monitoring, as the monitoring costscan be allocated over hundreds or thousands of patients who may begeographically scattered, since each dispenser does not have to includeits own control and actuation circuitry, analytical hardware andsoftware. The images and compliance information generated by thePillStation System are useful in clinical testing settings for preparingdocumentation for clinical trials necessary for submissions to the FDA.

As used herein, the terms “comprise,” “comprising,” “include,” and“including” are intended to be open, non-limiting terms, unless thecontrary is expressly indicated.

PillStation System Components

The dispenser of the PillStation System is based on conventional pillcontainers that are simple, familiar to patients and caregivers, lowcost, reusable, and capable of holding multiple medications ormedication reminder markers for medications that must be taken atspecific times.

In one embodiment, the device for the monitored storage and dispensingof medication includes a plurality of storage compartments, each havingan interior space for storing at least one medication or at least onemedication reminder marker; an image capturing device positionable tocapture an image of the interior space of each of the plurality ofstorage compartments; and a communications module for electronicallytransmitting the image captured by the image capturing device to acentral monitoring station. The communications module comprisesconventional electronics (e.g., transmitters, processors, memory) knownin the art for electronically transmitting an image or signal therefor.The device may further comprise an electronic communications componentfor communicating information to a user of the dispenser, from a user ofthe dispenser to the central monitoring station, or both to and from theuser. The communications component may include at least one audio,visual, or tactile means for communicating information. Examples includeLED and LCD displays, microphones, speakers, and vibration electronics.Electronics hardware and software is well known in the art for suchone-way and two-way communications.

Representative, non-limiting embodiments of the dispenser device areshown in FIGS. 1A-D, FIG. 2, and FIGS. 3A and B. FIGS. 1A-D show aschematic diagram of one embodiment of the dispenser. FIG. 1A shows atop perspective view of one embodiment of the device 100 in a closedposition, showing a visual display 102 for displaying information fromthe device to the patient, a speaker 106 for broadcasting audio signalsto the patient, and a microphone 104 for telephone, voice-over IP, andfor recording information from the patient or other user. FIG. 1B showsa perspective view of the same embodiment of the dispenser device 100 inan open position, showing a three-by-seven array 108 of storagecompartments 126. Each storage compartment 126 typically is capable ofaccommodating a plurality of medications 122 or medication markerreminders. FIG. 1B shows a dispenser 100 with a weekly unit 108 ofremovable storage compartments 126 for accommodating up to three dosageperiods per day (116, 118, and 120). Other variations of this dispenserdesign are envisioned, including monthly dispensers, bimonthlydispensers, and any of the foregoing with one, two, three, or fourdosage periods per day. In the embodiment shown in FIG. 1B, the storagecompartments 126 are removable as a single unit (e.g., as athree-by-seven array 108) or as two or more subunits 140 that correspondto one or more days of the week. FIG. 1B also shows the visual display102 for displaying information from the device to the patient, speaker106 for broadcasting audio signals to the patient, microphone 104 forrecording information from the patient or other user, “Select” button112, and “Call” button 114. The Select button 112 may be used to selectthe particular function the user desires to use (e.g., review messages,set alarm, review medication, display brightness, play music, getweather), and the Call button 114 may be used to select the particulartype of call the user desires to use (e.g., call for refill, callAdvisor at the central monitoring station, call pharmacy, call a familymember or caregiver, leave message for the central monitoring station orpharmacy). FIG. 1C shows a bottom perspective view of the sameembodiment of the dispenser device 100, showing the visual display 102for displaying information from the device to the patient, speaker 106for broadcasting audio signals to the patient, and microphone 104 forrecording information from the patient or other user. FIG. 1D shows aside view of the same embodiment of the dispenser device, which includesa safety lock 142. It is envisioned that a safety lock may be amechanical, electrical, or electromechanical lock as are known in theart.

FIG. 2 shows a cross-sectional side view of another possible embodimentof the device 200, not to scale, showing a dispenser body 238 withstorage compartments 226 for accommodating medications 222 or medicationreminder markers for up to three storage dosage periods per day (216,218, and 220). Each storage compartment 226 comprises a lid 224. Thedevice 200 comprises a power source 234, a camera 228 for capturingimages of the interior space of the storage compartments 226, and anetwork link 236 for transmitting and receiving signals from a centralmonitoring station.

FIGS. 3A and B show a schematic diagram of another embodiment of thedispenser 300. FIG. 3A is a partial exploded, perspective view, and FIG.3B is a cross-sectional view, in part, of the same embodiment of thedispenser device 300. In this embodiment, the camera 328 is mounted tomove on an X-Y platform 332 below an array 308 of storage compartments326 to focus on a transparent bottom of each storage compartment 326 inorder to capture an image of the interior space of a storage compartment326. Each storage compartment 326 comprises a lid 324. In oneembodiment, each storage compartment may be selectively lighted (e.g.,by an LED 330) to provide illumination for digital visual image captureand/or for highlighting the medication dose 322 the patient needs totake at a particular time. It is envisioned that a camera 328alternatively may be mounted on a non-movable platform. This schematicdiagram also shows the power source 334 and network link 336.

In one embodiment, the dispenser is made of an optically transparentmaterial, such as a polymer, e.g., polycarbonate, or the like, at leastin the bottom of the compartments between the medication and theimage-capturing device. The bottom side of the storage compartment coverdesirably may be less transparent such that the light is appropriatelyspread in the bin to maximize imaging results.

The image capturing device may include one or more digital stillcameras, video cameras, or the like as is known in the art. The imagecapturing device may be oriented to view all or some of the storagecompartments in the dispenser, but if less than all, then one or moreadditional image capturing devices typically would be included. A singlecamera may be provided in a fixed location within the dispenser, or thecamera may be configured to move to different positions within thedispenser. The camera may include focusing means, zoom means, and/ormirrors in order to enhance image capture of each compartment or to vieweach compartment from different angles as needed. The camera also maycomprise a polarizing filter on the lens. The images captured preferablyare high resolution color images, but may be black/white. The images maybe digital still images, and transmitted in various formats known in theart. The images may be high definition images. In some embodiments, theimage capturing device is a video camera, capable of live monitoring ofthe dispenser device and/or its usage. In one embodiment, the videocamera, as well as the microphone and speaker, are activated upon anaudio trigger in the room where the dispenser device is located,allowing the patient to transmit questions to the central monitoringstation and/or to allow the central monitoring station to guide thepatient as the patient is taking his or her medications.

The storage compartments may comprise a cover that may be variouslydesigned. In one case, it may include a design in which the cover flapprotrudes outward to allow a user to insert his or her finger thereunderto flip open the flap and push the flap back, thereby opening thestorage compartment cover in order to load the interior space of thestorage compartment with medication or to permit removal of medicationfrom the storage compartment. In one variation, the storage compartmentis designed to facilitate ease of removal of the pill or othermedication from the storage compartment. For example, the cover openingmay have an additional cover extension in the storage compartment, andwhen the flap is pushed back, not only the cover lifts up and moves backbut a bottom cover extension moves upward toward the opening, bringingthe pill to the surface for ease in removal. In certain embodiments, thestorage compartments are identified by a cover label or other uniquemarking such that the image view can easily identify if the storagecompartments have been placed correctly. In certain embodiments, the lidand interior surfaces of the storage compartments are black or othersuitable color to minimize reflections in the imaging.

For example, the storage compartments may have dimensions capable ofhold a plurality of pills and/or larger medication delivery devices. Forexample, these medications may be in the form of tablets or capsules(which may be referred to as “pills”). In other embodiments, the storagecompartments are dimensioned to hold other pharmaceutical dosage formsand unit dose containers. For instance, the bins may hold transdermalpatches, “lollipop”-like medication sticks (which are inserted in mouthfor breakthrough pain), injections, tubes, etc. For such applicationswhere the medication may not fit properly in small storage compartments,such as those illustrated in FIG. 1B, FIG. 2, or FIG. 3A, the containercomprising the multiple storage compartments may comprise differentsizes and/or shapes of storage compartments, while preferably keepingthe lower imaging system identical.

In other embodiments where the medication will not fit properly in thestorage compartment, a medication reminder marker may be placed in thestorage compartment. As used herein, a “medication reminder marker”comprises an indicator that a particular medication is to be taken atthat time period corresponding to the storage compartment. Themedication reminder marker may be a coin-sized chip, in one embodiment.The medication reminder marker may be made from any suitable substancecompatible with the dispenser system. For example, in one embodiment,the medication reminder marker is an object made from a polymer. Inpreferred embodiments, the medication reminder marker has a shape andcolor selected to match a shape and color code present on a label of aprescribed medication. In certain embodiments, the prescribed medicationis selected from the group consisting of an inhaler, a vial of aninjectable medication (e.g., insulin) a parenteral, a patch, or a“lollipop”-like medication stick. The prescribed medication may be aninhaler or a parenteral medication.

The dispenser may include a display (e.g., an LED or LCD) that shows thedate, time of day, or both the date and time of day, as well as fordisplaying messages to the user, for example, regarding compliance withthe patient's medication dosage schedule. The dispenser desirably isportable and may be operated by a rechargeable battery. In oneparticular embodiment, the rechargeable battery may be charged using aDC adaptor. Desirably, a power LED or other signal indicates whencharging is required. In one embodiment, the dispenser device comprisesa speaker, through which an audio alert may be used to indicate whencharging is required or to broadcast a message to the user, for example,regarding compliance with the patient's medication dosage schedule,instructions, or other information (e.g., “Please take yourmedications,” “Please press reset button located on the side,”“Medication filled or new medication added—please doublecheck,” “Messagefrom your doctor—please take this pill on an empty stomach,” “You aredoing excellent in taking your medications—you have not missed any dosesin the last 5 days”). The dispenser device also may comprise amicrophone for the user to transmit a message, for example, to thecentral monitoring station, physician, or pharmacy. In otherembodiments, the dispenser device may be configured to be compatiblewith other wireless health-related devices (e.g., a blood pressuremonitor), such that information from the other health-related devicealso may be transmitted to the central monitoring station. In addition,the dispenser device may be configured such that it is compatible with aroom monitoring device (e.g., a home security system), wherein thedispenser device can monitor when a significant change takes place andnotify the patient's family member and/or healthcare provider of suchchange.

In one embodiment, the top, storage compartment portion of the dispensercan be conveniently separated from the bottom, imaging system portion ofthe dispenser. This replaceably removable container may be particularlyuseful if the patient is traveling and desires to take the dispenserwithout transferring the medication. It also will facilitate washing ofthe compartments if necessary. The top and bottom portions of thedispenser may be releasably secured together using one or more snaps,clips, latches, or other fasteners known in the art. The storagecompartments may be separated from the bottom portion of the dispenseras a single larger container, or the storage compartments may be removedas two or more subunits of the single larger container, wherein eachsubunit comprises two or more storage compartments. In one embodiment,the subunit corresponds to the storage compartments corresponding to atleast one day of the week. In one embodiment, the subunits may beprovide to the patient preloaded with a medication; the subunit storagecompartments may be designed to be single use, disposable container.

In a preferred embodiment, the dispenser includes a network link viatelephone line, wireless gateway (e.g., WiFi, ZigBee, Bluetooth), orcellular network which transmits processed images to a centralmonitor/control station. Advantageously, the network based systemdistributes analysis cost over the entire user base rather than packingelaborate control circuitry into each peripheral unit. The dispenseradvantageously may be monitored at an alternate location when thepatient is traveling, through the use of the network link as described.

The frequency and timing of calls to the camera of the PillStationSystem may be adjusted as needed for the particular patient andmedication. For example, frequent, random calls may be scheduled todetect and deter abuse, or infrequent, regular calls may be scheduled tomonitor compliance. The physician may adjust the schedule as needed.

Computer assisted operators may verify accuracy of medication loading,document compliant use of medication per physician instructions, andrule out misuse of medications that may be prone to abuse. Reports ofcall results may be generated and delivered to the patient, to thepatient's physician, or others as desired. For example, a secure on-linecompliance report may be made available for the patient's family.

In one embodiment, only one image is captured per day, stored, in-placeprocessed, and forwarded to a gateway. This processing can be in realtime or non-real time as long as there is no significant power drain.

In certain embodiments, the dispenser device comprises at least twobuttons, a “Select” button and a “Call” button. The Select button may beused to select the particular function the user desires to use (e.g.,review messages, set alarm, review medication, display brightness, playmusic, get weather), and the Call button may be used to select theparticular type of call the user desires to use (e.g., call for refill,call Advisor at the central monitoring station, call pharmacy, call afamily member or caregiver, leave message for the central monitoringstation or pharmacy). In certain other embodiments, the dispenser devicefurther comprises an up and/or down arrow buttons for scrolling throughpossible choices visually displayed on the display screen. In certainembodiments, a remote control that is configured to be compatible withthe dispenser device may be used.

In another embodiment, the device comprises a security or useridentification module to confirm the identity of the person accessingthe contents of the storage compartments in the device. The security oruser identification module may be structured such that it can detect afingerprint, biometric shape of the user's hand or finger, or retinalscan profile. Alternatively, the module may employ voice recognitiontechnology. In one embodiment, the camera that captures images of theinterior space of the storage compartments is used to capture images ofthe user's finger before allowing access to the contents of the storagecompartments.

As used herein, the terms “medication dosage schedule” or “medicationdosage regimen” are used to describe a schedule for taking one or moreprescription medications and/or one or more OTC medications. As patientsoften will receive prescriptions from more than one physician orspecialist, the PillStation System may be used to detect the occurrenceof harmful interactions between different prescription and/or OTCmedications prescribed by or recommended by the multiple physicians orspecialists. The PillStation may be used to prevent the harmfulinteractions by transmitting a signal to the patient's dispenser, whichmay be audibly broadcasted, e.g., from a speaker, or displayed on thevisual screen. In addition or in the alternative, a computer assistedoperator at the central monitoring station may contact the patientand/or his or her primary physician (e.g., by telephone, email, textmessage, etc.) to warn of such a possible harmful interaction. Inaddition, the PillStation System may be used to monitor a schedule forother health-related matters, e.g., to monitor a patient's suggestedexercise regime and to provide positive reinforcement for compliancewith the same.

In some embodiments, the dispenser device may be configured toautomatically call the patient's pharmacy and alert the patient when alow dosage is detected. In other embodiments, the user may add a memorystick or hard drive through the USB port of the dispenser device inorder to listen to music.

In one embodiment, the dispenser device may include one or more localsensors and local electronic communication components for communicatingwith the patient without interaction by (e.g., without going through)the central monitoring system. For example, the dispenser may locallyinclude a sensor and microprocessor capabilities for detecting whetherall of the medications have been removed from one or more of the storagecompartments. The dispenser could then display or broadcast locally analert to the user of an abnormal condition with the dispenser device orits contents. More complex processing, such as reconciling theprescribed mediation regimen with medication loaded in the storagecompartments would still be conducted at the remote monitoring stationvia the captured images. The local detection mean can be independent ofthe image capture and analysis.

User Profiles

As used herein, a “patient” is a human being in need of at least oneprophylactic or therapeutic medication. The term “user” is usedinterchangeably with the term “patient.” The medication typically is aprescription medication, but also may be an over-the-counter (OTC)medication. In a preferred embodiment, each user of the PillStationSystem has a unique user profile which lists personal information (name,address, etc.) about the user as well as the details of their medicationinformation, including their medication dosage schedule. Non-limitingexamples of different user types may include mid-late life or elderlypatients (e.g., patients with an average age of 79 years old that maysuffer from multiple chronic diseases, short memory, and/or arephysically challenged), patients with complex multi-medication regimens,depression patients (e.g., patients may be of any age range), childpatients, and medication abuser/diverter patients. The user profile canbe stored either on the device itself or at the central monitordepending on the requirements of the system. In some embodiments, theuser profile also will include distinguishable physical identityinformation (e.g., fingerprint, biometric shape of fingers or hands,retinal scan profile) in order to ensure the patient is the one whoaccesses the medication in the dispenser device.

Home Installation and Use of the PillStation System

In a particular embodiment, the PillStation dispenser may be deliveredto a user already on a partner gateway. The PillStation dispenser may bepre-configured for compatibility with the gateway, including allpertinent information for establishing the connection. The gateway alsomay be re-configured upon receipt by the user (e.g., live on-line orduring past transmission). The user may link the dispenser to thegateway using any method known to those skilled in the art. For example,the user may press a button on the PillStation dispenser to enablecommunication between the gateway and the dispenser. Desirably, averification of the link between the dispenser and the gateway will beprovided to the user. Such verification may be any method known in theart; non-limiting examples include an audio/voice response and/or apower LED blinking from red to green.

After establishing communication between the dispenser and the gateway,the dispenser is filled with the appropriate medications and dosages. Inone embodiment, the user loads the storage compartments according to amedication dosage schedule. In other embodiments, the storagecompartments are loaded by an automated dispenser, a physician, apharmacist, caregiver, or other healthcare provider. In a particularembodiment, the user may verify that the medication has been loaded intothe storage compartments appropriately. For example, the user may berequired to press a button or there may be an audio prompt instructingthe user to take certain steps in order for the device to capture animage and transmit it to the central monitoring station for reviewing.In another particular embodiment, the dispenser may be used to verifyappropriate loading of medications and dosages. In another embodiment,the automated dispenser, physician, pharmacist, caregiver, or otherhealthcare provider may verify that the medication has been loaded intothe storage compartments appropriately.

The PillStation dispenser may alert a user when it is time to takemedication by audible, visual, or others modes of communication known inthe art. For example, in one embodiment, the dispenser alerts the userby blinking and/or lighting up. In another embodiment, the dispenser mayprovide an audio alert to the user. In still another embodiment, theuser may set time restrictions on activation of the alert system inorder to avoid interruptions (e.g., the alert may be silenced throughdinner).

In one embodiment, the dispenser desirably provides audio or videoinstructions for taking the medication (e.g., “Please take one Lipitorand one folic acid tablet with your meal.”). The dispenser device mayhighlight the compartment from which the medication is to be withdrawn.For example, the imaging subsystem may even move to the storagecompartment to show the user specifically which medication it is. Thedispenser also may be used to provide messages to the user from theobservers/computer operators regarding compliance with the medicationdosage regimen (e.g., “Hi Mrs. Jones—you missed taking your medsyesterday—please be sure to take them today.”). In another embodiment,both audio/video instructions and feedback are provided in order toshape compliance behavior. For example, a dispenser may broadcast a toneand the LED below the appropriate storage compartment may blink,starting an interval in which taking the medication will be reinforced.If the LED blinks for a 30 minute time interval, then upon removal ofthe medications and/or medication reminder markers from that storagecompartment, the LED will glow and a message of positive reinforcementwill be displayed. If the removal does not occur until after theparticular time window, then there will be no glow or positivereinforcement. Instead the display message may state “Take your pillsnow” or “Your pills work best when taken at the right time.” Thispattern of reinforcement is particularly useful in shaping timelycompliance behavior which is critical for many medications (e.g.,medications for treating asthma, diabetes, congestive heart failure).

In addition, the dispenser device also may be used to provide messagesto the user regarding other health-related issues (e.g., to remind apatient to exercise, to ask a patient to refrain from drinking, doingdrugs, or gambling (for patients with known history of these diseases orhabits), to ask a patient to stay away from foods high in sugar content(for patients with diabetes), to ask a patient not to go outside in coldtemperatures (for patients with arthritis, to remind a patient ofappointment times, etc.).

In one embodiment, the user (or his/her family or caregiver) can goon-line and view an image of their pill dispenser and theirprescriptions. The user also may be able to review what pills need totaken and when the pills need to be taken. In addition, the user and/ortheir family or caregiver can perform various functions by visiting anonline page and/or by sending email instructions. (e.g., registering,billing, creating profiles, setting preferences, setting alarms, viewcall logs, view compliance report, view messages to the users, viewfrequently asked questions, view medication input, communicate with thecompliance monitoring station).

In one embodiment, the dispenser hardware and electronics are tamperresistant or tamper proof. The device may comprise a child safety lock,to prevent a child's access to the medication storage compartments. Insome embodiments, when tampering occurs, the patient is alerted by amessage transmitted to the local computer, land-line telephone line,cellular phone, or as a text message.

In one embodiment, the dispenser device can join in a telephone call inprogress, when requested by the patient by making a particular keystroke(e.g., if user and caregiver are talking, they can press a particularcombination of buttons, and the dispenser device will “wake up” and cangive compliance status to both parties on call, allowing the caregiverto share the data directly from the pill station in the middle of thecall.).

Monitoring of the PillStation Dispenser

Medication compliance is monitored by the PillStation dispenser using animage capturing device, such as inexpensive camera or similar device, tocapture images of the medication or medication reminder marker andthereafter upload the images to the gateway as shown schematically inFIG. 4. The image may be compressed or otherwise processed as known inthe art to facilitate electronic transmission of images. In oneembodiment, the camera is capable of visualizing a font size of 6 on themedication. In another embodiment, the camera is capable of visualizingmedications of different colors, shapes, and sizes. For example, thecamera desirably may be designed and oriented in relation to thedispenser bins in order to be capable of visualizing small medicationsthat are approximately 6.0 mm in diameter having markings ofapproximately 1.0 mm high and approximately 0.6 mm wide.

In another embodiment, the medications may have numbers inscribed acrossthe top/bottom surface such that some of the exposed numbers can beresolved. In one example, these inscribed numbers may be on a whitepill. In one embodiment of the dispenser device, the camera is capableof visualizing these inscribed numbers through the bottom of thedispenser. The dispenser and camera may be designed to utilize ambientlight (e.g., from the room in which the use locates the dispenser) inthe image capturing process. Alternatively or in addition, the dispensermay include a flash, LED, or other illumination source built into thedispenser, e.g., located in the bottom of the dispenser to emit lightinto each of the bins to be imaged. The illumination source may bemovable, e.g., with a selectively positionable camera.

In one embodiment, a reference mark on the bottom of the dispenser isused to pre-calculate an “area of interest” upon start of thescan/imaging, permitting only the area of interest to be imaged andother areas discarded. This reference mark calibration may be requiredonly infrequently, depending on the electro/mechanical assemblytolerance shifts over time.

The dispenser communicates with the central monitor through means suchas wireless communication, telephone communication, or through acellular network. Those of ordinary skill in the art will appreciatethat different adapters may be required for each type of communication(e.g., WiFi dongle, zigbee dongle, powerline dongle, bluetooth dongle).Desirably, the communication adapter is connected to the PillStationdispenser through a USB interface, thereby allowing different kinds ofhardware to be interchanged more easily. The dispenser desirablyself-detects the adapter and configures appropriately to the network. Ina particular embodiment, if a USB adapter driver is not available, anoption may be available to insert a USB memory stick with the driverswith only the required adapter being loaded.

In one embodiment, the images captured by the PillStation dispenseroriginally are stored in local memory and then transmitted to thecentral monitoring station. At the central monitoring station, imagerecognition software (e.g., OCR and other software) may be utilized todetermine the type/number of pills left. Each PillStation dispenserpreferably has a unique ID number and a password, allowing thePillStation dispenser to be linked automatically to the correct userprofile and medication dosage schedule. The data analyzed by the imagerecognition software then may be compared to the user's profilemedication dosage schedule to determine the user's compliance in takingmedication.

In certain embodiments, an observer at the central monitoring stationmonitors the patient's dispensers to determine the patient's compliancewith his or her medication dosage schedule. The monitoring center may belocated in a time zone shifted about 12 hours for the patientpopulation, so that observers working a day shift could monitor thepatients' dispensers when the patients are typically asleep. In certainembodiments, if the observer observes a major error in compliance withthe user's dosage medication schedule, the observer will notify the userand/or a second observer that may communicate with the user. If theerror in compliance cannot be resolved, the second observer may notify apharmacist who may review the error and consult the user, user'sphysician, family member, and/or insurance provider.

The data (i.e., captured images) may be collected as frequently and/orrandomly as needed as determined by the physician and thegateway/central monitoring station. Non-limiting examples of supportedmodes for data collection include once per day at a time to bedetermined, many times a day at a time to be determined, or randomlywith a settable frequency. In one embodiment, the frequency of imagecapture may decrease when the battery power is low.

In certain embodiments, if the captured image transmitted to the centralmonitoring station matches what is expected for the patient's medicationdosage schedule, information is transmitted to the dispenser forpositive reinforcement (e.g., “Great job, Ms. Jones!”). Positivereinforcement may be continuous (i.e., after each dosage is taken ontime), or intermittent (i.e., variable time between operator fullmonitors, to be done randomly, to reward compliance with dosagemedication schedule without errors in time, omissions, or overuse). Incertain other embodiments, when the captured image transmitted to themonitoring station does not match what is expected for the patient'smedication dosage schedule, the central monitoring station transmitspersonalized instructions about the medication error to the dispenserdevice. The instructions may be visually displayed on the display screenand/or audibly broadcast. In certain other embodiments, if such amedication error is repeated for one or more times, the centralmonitoring station may transmit a signal/message to the patient'scaregiver, physician, or other healthcare provider.

In another embodiment, the dispenser device is able to detect if amedication or medication reminder marker is present in a storagecompartment or if the storage compartment is empty (i.e., if allmedications were taken from the storage compartment), and can transmit amessage to the patient if less than all of the medications or markerswere removed.

Medication Image Processing

In a preferred embodiment, the image transmitted to the central monitorfrom the camera is minimally compressed. In various embodiments, severalprocessing/analysis algorithms may be executed to further reduce theimage size. For example, the image processing may include:

-   -   1. Discard images of empty bins—Each bin can be processed        separately and upon an empty bin signature, that image need not        be kept. Also, through historical trend as well as knowledge of        the prescription ID number and the number and types of pills        that need to be taken, one can verify the location and day of        empty bins.    -   2. Discard images with no change—If there is a strong        correlation between last image and current one, then this data        can be discarded as well.    -   3. Image cropping—Only the image of the bin with area of        interest is required hence other segments of the images can be        discarded.    -   4. Lossless image compression: For some of the bins some simple        lossless compression may be required.

The present invention has numerous advantages over prior art dispensingdevices and monitoring systems. Such advantages include verificationthat appropriate medications have been loaded into the dispenser,surveillance for both abuse and non-adherence, reduced costs, andbehavioral modification with positive reinforcement.

For processed images which still are below the acceptable thresholdconfidence factor (of types, number, etc. of medications as specified inRx or expected), these images may be sent to a central operator. Theseoperators can view storage compartment images alongside names andreference images of pills that should be in the bin, such thatcomparisons between the image received and the expected image can bemade rapidly. To maintain quality control, test images may be insertedand operator performance can be monitored in real-time. Such a systemcan be used for operator training as well.

It should be apparent that the foregoing relates only to exemplaryembodiments of the present invention, and that numerous changes andmodifications may be made therein without departing from the scope ofthe invention as defined by the following claims.

We claim:
 1. A device for the monitored storage and dispensing ofmedication to a user comprising: a plurality of user-accessible storagecompartments, wherein each storage compartment has an interior space forstoring at least one medication or at least one medication remindermarker, and wherein the plurality of user-accessible storagecompartments are presented and arranged together in order of amedication dosage schedule in which the at least one medication or theat least one medication reminder marker is to be removed from each ofthe plurality of user-accessible storage compartment by the user; animage capturing device configured to capture at least one image of theinterior space of the plurality of user-accessible storage compartments;and a communications module for electronically transmitting the imagecaptured by the image capturing device to a central monitoring station.2. The device of claim 1, wherein each user-accessible storagecompartment comprises a wall through which the image can be captured,for direct visualization of any medication or medication reminder markerwithin the interior space of the user-accessible storage compartment. 3.The device of claim 1, wherein the plurality of user-accessible storagecompartments is provided in an array corresponding to the days of theweek and periods of time throughout the day.
 4. The device of claim 1,wherein the plurality of user-accessible storage compartments arereplaceably removable from the device.
 5. The device of claim 4, whereinthe plurality of user-accessible storage compartments are removable intwo or more subunits of two or more storage compartments.
 6. The deviceof claim 5, wherein each subunit comprises storage compartmentscorresponding to at least one day of the week.
 7. The device of claim 1,wherein the image capturing device comprises a stationary camera.
 8. Thedevice of claim 7, wherein the camera comprises a digital still cameraor a digital video camera.
 9. The device of claim 1, wherein thecommunications module for electronically transmitting at least a portionof the captured image comprises a network link for a telephone line,power line, wireless gateway, or cellular network.
 10. The device ofclaim 9, wherein the network link comprises an embedded or donglecircuitry for WiFi, zigbee, powerline, or bluetooth transmissioncircuitry.
 11. The device of claim 1, further comprising an electroniccommunications component for communicating information to a user of thedispenser, from a user of the dispenser to the central monitoringstation, or both to and from the user.
 12. The device of claim 11,wherein the information communicated to the user comprises battery powerlevel or other operational status information about the device.
 13. Thedevice of claim 11, wherein the information communicated to the usercomprises information about the user's compliance with his or hermedication dosage schedule.
 14. The device of claim 11, wherein theinformation communicated from a user of the dispenser to the centralmonitoring station comprises personal identity information of the userof the dispenser.
 15. A patient medication compliance monitoring systemcomprising: at least one visually monitored medication dispenserassigned to an individual patient having a medication dosage schedule,wherein the medication dispenser comprises (i) a plurality ofuser-accessible storage compartments, wherein each compartment has aninterior space for storing at least one medication or medicationreminder marker, and wherein the plurality of user-accessible storagecompartments are presented and arranged together in order of amedication dosage schedule in which the at least one medication or theat least one medication reminder marker is to be removed from each ofthe plurality of user-accessible storage compartment by the user, (ii)an image capturing device configured to capture at least one image ofthe interior space of the plurality of user-accessible storagecompartments, and (iii) a communications module for electronicallytransmitting the image captured by the image capturing device to acentral monitoring station; and a central monitoring station that iscapable of receiving and viewing the image transmitted from the at leastone medication dispenser.
 16. The compliance monitoring system of claim15, comprising a plurality of visually monitored medication dispensers,wherein each medication dispenser is assigned to a different individualpatient having a medication dosage schedule.
 17. The compliancemonitoring system of claim 15, wherein the image capturing devicecomprises a stationary camera, and the communications module forelectronically transmitting the captured image comprises a network linkfor a telephone line, wireless gateway, or cellular network.
 18. Thecompliance monitoring system of claim 15, wherein the medicationdispenser further comprises an electronic communications component forcommunicating information to a user of the dispenser, from a user of thedispenser to the central monitoring station, or both to and from theuser.
 19. The compliance monitoring system of claim 15, wherein themedication dispenser is adapted to receive image capture instructionsfrom the central monitoring station.
 20. The compliance monitoringsystem of claim 15, which comprises the use of at least one computer.